A Study of Safety, Reactogenicity and Immunogenicity of HRV Vaccine in HIV Infected Infants in South Africa

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The aim of this study is to evaluate the reactogenicity, safety and immunogenicity of GSK Biologicals' human rotavirus (HRV) vaccine given concomitantly with routine vaccines including OPV in HIV positive infants. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

HIV infected infants as determined prior to study entry (screening) and asymptomatic or mildly symptomatic (WHO stages I and II) of disease will be enrolled. The study will have two groups: Group HRV and Group Placebo. Three-dose immunisation will be administered at approximately 6, 10, and 14 weeks of age. Routine EPI (Expanded Program on Immunisation) vaccinations will be administered concomitantly with the study vaccines. At the time of first dose, subjects will be aged 6 to 10 weeks. This study will evaluate safety, reactogenicity and immunogenicity of the HRV vaccine relative to the placebo.

Number of Subjects Reporting Any Unsolicited Symptoms. [ Time Frame: Within 30 days after each dose ]

An unsolicited symptom was any spontaneously reported untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Number of Subjects Reporting Any Serious Adverse Events. [ Time Frame: Until 2 months after dose 3 (for subjects RV negative at Day 42 post-dose 3) or until end of RV shedding (for subjects who shed RV at Day 42 post-dose 3). ]

results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

Number of Subjects Reporting Each Type of Solicited Symptom. [ Time Frame: Within the 15-day solicited follow-up period after each dose ]

The Number of Subjects With no Evidence of Immunosuppression and Moderate/ Severe Suppression, Based on CD4+ Absolute Cell Count and CD4+ Percent. [ Time Frame: At the screening visit and 2 months after dose 3 (Visit 4). ]

Number of Subjects Who Seroconverted Against Rotavirus [ Time Frame: Two months after dose 3 ]

A subject with anti-rotavirus Immunoglobulin (IgA) antibody concentration < 20 units/milliliter (U/mL) before vaccination and ≥ 20 U/mL after vaccination is considered as seroconverted.

Number of Subjects With Vaccine Take. [ Time Frame: Two months after the dose 3 ]

Vaccine take: appearance of serum IgA to rotavirus at a concentration of ≥ 20 U/ml or rotavirus shedding in any stool sample collected from the Screening Visit to 2 months after dose 3 for subjects initially negative for rotavirus.

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Ages Eligible for Study:

6 Weeks to 10 Weeks (Child)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.

A male or female between, and including 6 and 10 weeks of age at the time of the first vaccination.

Written informed consent obtained from the parents or guardians of the subject

Documented HIV status of the subject as confirmed by PCR.

HIV asymptomatic and HIV mildly symptomatic; Stages I and II disease according to WHO's most recent classification for HIV stages in infants and children.

Born after a gestation period of 36 to 42 weeks.

Exclusion Criteria:

Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.

Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator.

History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.

Acute disease at time of enrolment.

Gastroenteritis within 7 days preceding the study vaccine administration.

Previous confirmed occurrence of RV gastroenteritis.

Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.